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Search / Trial NCT05925959

Preoperative Weight Loss for Open Abdominal Wall Reconstruction

Launched by BENJAMIN T. MILLER · Jun 22, 2023

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the impact of weight loss before surgery on patients with abdominal wall hernias. Specifically, it aims to see if patients who follow an intensive weight management program before their surgery have a similar quality of life related to their abdominal wall compared to those who go straight to surgery without losing weight first. The researchers want to find out if losing weight ahead of time can help improve recovery and overall satisfaction after the surgery.

To be eligible for this trial, participants need to be adults aged 65 to 74 who have a specific type of abdominal hernia repair planned and have a body mass index (BMI) between 40 and 55. This trial is particularly for those who aren’t planning to have weight loss surgery for various reasons, such as not qualifying for it or not being interested. Those who join can expect to either participate in a weight management program or go directly to surgery, and their quality of life will be assessed afterward to see which approach is more beneficial. It's important to note that this study is currently recruiting participants.

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh
  • BMI 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery.
  • Exclusion criteria
  • Lack of English language fluency
  • Urgent need for repair as determined by surgeon judgement
  • Pregnant patients
  • Permanent stoma in place
  • Isolated flank hernia
  • Anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction.
  • BMI \<40 or \>55 kg/m2
  • Inability to participate in the Obesity Management Program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.).
  • Obstructive symptoms

About Benjamin T. Miller

Benjamin T. Miller is a distinguished clinical trial sponsor known for his commitment to advancing medical research and innovation. With extensive experience in the pharmaceutical and biotechnology sectors, Mr. Miller oversees the design and implementation of clinical trials aimed at evaluating new therapeutic interventions. His leadership is characterized by a focus on rigorous scientific methodology, regulatory compliance, and ethical standards, ensuring the safety and well-being of trial participants. Through collaboration with academic institutions and industry partners, Benjamin T. Miller strives to accelerate the development of groundbreaking treatments that address unmet medical needs.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Benjamin T Miller, MD

Principal Investigator

The Cleveland Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported